Effects of an Individual and Family Self-Management of Fall Prevention Program on Balance Ability and Fall-related Self-efficacy Among Chinese Post-Stroke Individuals

Not Applicable

Active, not recruiting

• Conditions: Stroke, Ischemic; Self Efficacy; Fall

• Registration Number: NCT06577662
• Lead Sponsor: Chiang Mai University

Brief Summary

This study is about exploring the effectiveness of individual and family self-management (IFSM) fall prevention programs on balance ability and fall-related self-efficacy in post-stroke people. The main intervention measures were developed based on the risk and protective factors of fall prevention in post-stroke people, including exercise, environment safety, assistant technology, medication review, and safety in daily activities. The intervention was implemented in 10 weeks for both patients and their family members. By mastering these skills, post-stroke people may reduce the number of falls after discharge to home.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-08-27
• Study First Submitted QC: 2024-08-27
• Study First Posted: 2024-08-29
• Study Start: 2024-10-01
• Status Verified: 2025-06
• Last Update Submitted: 2025-06-26
• Last Update Posted: 2025-06-29
• Primary Completion: 2025-06-30
• Study Completion: 2025-06-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• For patients

  • aged 18 years or above;
  • first-ever diagnosed with ischemic stroke;
  • level of impairment assessed by the National Institutes of Health Stroke Scale (NIHSS) scores between 5 to 15 (moderate severity) before entering the experiment;
  • mental state assessed by Mini-Mental State Exam score > 24;
  • mobility tested by Timed Up and Go ≥12.6 second (walkers or another kinds of gait aid are allowed to be used in the test);
  • motor power of all limbs examined by muscle power assessment grade ≥3;
  • ability to understand Chinese;
  • living with family members;
  • having phones that can use the internet;
  • willing to join the study.

• For caregivers

  • mental state assessed by Short Portable Mental Status Questionnaire score ≥8;
  • being the primary caregiver, living in the same house, and taking care of the patient;
  • having phones that can use the internet;
  • can speak, understand, and write in Chinese; and (e) willing to participate.

Exclusion Criteria for patients:

• having problems with sensory and/or global aphasia

Discontinuation criteria:

• patients have an illness that needs hospitalization;
• patients and caregivers cannot complete participation in intervention sessions.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Fall-related self-efficacy	Fall-related self-efficacy will be measured before the fall prevention program and after patients are discharged in 8 weeks.	Fall-related self-efficacy refers to the level of perceived confidence in undertaking everyday activities without falling, which includes self-efficacy in balance ability, preventing falls, and managing falls. The Short Falls Efficacy Scale-International (Short FES-I) will be used to assess fall-related self-efficacy; it consists of seven questions. A four-point scale is used to score each item, and a higher score indicates lower self-efficacy. The total score is calculated by adding the scores of each item, giving a scale ranging from 7 to 28 for the seven items. The Short FES-I has previously demonstrated excellent reliability (Cronbach's α = 0.92).
Balance ability	Balance ability will be measured before the fall prevention program and after patients are discharged in 8 weeks.	Balance ability is the ability to maintain the body's stability, including keeping a certain posture or balance when subjected to external forces. Berg Balance Scale (BBS) will be used to assess the balance ability in post-stroke people. The BBS will be used to assess balance ability in post-stroke individuals. It consists of 14 items, each rated on a five-point scale. A score of 41-56 indicates the ability to walk independently, 21-40 indicates the ability to walk with assistance, and 0-20 indicates wheelchair-bound movement. In different studies on patients with stroke, the BBS has been found to have excellent internal consistency, with Cronbach alphas ranging from 0.92 to 0.98

Secondary Outcome Measures

Name	Time	Method
Number of falls, fall-related injuries and Adverse Events	Number of falls and fall-related injuries will be measured after patients are discharged in 8 weeks

Trial Locations

Locations (1)

Affiliated hospital of Guizhou Medical University; 🇨🇳 Guiyang, Guizhou, China